Prevention of human cytomegalovirus (HCMV) mother-to-fetus transmission by administration of virus-specific hyperimmune globulin to pregnant women with primary HCMV infection - ND
- Conditions
- Pregnant women with primary HCMV infection.
- Registration Number
- EUCTR2008-006560-11-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
pregnant women, >/= 18 years, primary HCMV infection at 5-26 week of gestation, Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1)multiple pregnancy, 2)history of HIV infection, 3) known immunodeficiency or immunosuppression, 4) congenital or required auotimmune desease 5) known intollerance to proteins of human origin, 6) hypersensitivity to human immunoglobulin, 7) suspected serious organic or psychiatric desease 8) not willing to give informed consent, not willing to give consent to treatment of personal pseudonymised data.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method